CTGB03TP3

Aerex^® 0.2 µm、カートリッジ

pore size 0.2 μm, cartridge nominal length 30 in. (75 cm), Code 0 (2-222; O-rings)

• 別名: Aerex CTGB Cartridge Filter 30 in. 0.2 µm Code 0
• UNSPSCコード: 23151806
• eCl@ss: 32031690

特性

• 物質: PTFE ; polypropylene ; polypropylene support; silicone seal
• 品質水準: 400
• 無菌性: non-sterile
• 滅菌適合性: steam-in-place compatible
• 製品種目: Aerex^®
• 特徴: hydrophobic
• メーカー／製品名: Aerex^®
• パラメーター: ≤45 mL/min nitrogen diffusion at 690 mbar (10 psig) and 23 °C (in 60/40% IPA/water); 0.35 bar max. differential pressure (5 psid) at 145 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 145 °C (Forward); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 5.2 bar max. differential pressure (75 psid) at 25 °C (Reverse; intermittent); 5.2 bar max. inlet pressure (75 psi) at 25 °C (Reverse); 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward); 7 bar max. inlet pressure (100 psi) at 25 °C (Forward)
• テクニック: gas filtration: suitable
• L: 30 in.
• W: 2.7 in.
• カートリッジの長さ（公称）: 30 in. (75 cm)
• 直径: 6.9 cm (2.7 in.)
• ろ過面積: 1.95 m²
• 不純物: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 重量分析抽出物: ≤105 mg/cartridge
• Matrix: Aerex^®
• ポアサイズ: 0.2 μm pore size
• 入力: sample type gas
• 泡立ち点: ≥900 mbar (13 psig), nitrogen with 60/40% IPA/water at 23 °C
• カートリッジコード: Code 0 (2-222; O-rings)

詳細

詳細

Device Configuration: カートリッジ

特徴および利点

This product has been qualified to retain a ΦX174 virus aerosol challenge of 10⁸ to 10¹⁰ PFU at an air flow rate of 50 SCFM per 10-inch cartridge after 50 steam-in-place cycles at 145 °C.

包装

イージーオープン バッグ

その他情報

これらの製品はFDAの定めたGMP準拠の製造工場で製造されています。

Directions for Use

• Organism Retention: Microorganism
• Mode of Action: Filtration (size exclusion)
• Application: BioProcessing
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer Steam Sterilization & Integrity Testing Procedures guide and first page of Visual Inspection Guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

品質

The membrane has been qualified to retain bacteria when challenged for 21 days with a minimum Brevundimonas diminuta aerosol concentration of 1 x 10⁷ CFU/cm².

調製ノート

Sterilization Method
145 °C 30 分のSIP 200回 (正方向 150/逆方向50)

This product was manufactured with a PTFE membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

アナリシスノート

HydroCorr: ≤0.40 mL/min per 10-inch cartridge with water @ 1380 mbar (20 psig)

Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature

法的情報

AEREX is a registered trademark of Merck KGaA, Darmstadt, Germany